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China NMPA New Approvals in October 2023

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In October 23, a total of 221 medical device products were approved by China National Medical Product Administration (NMPA). Among them, there are 176 domestic Class III medical device products, 28 imported Class III medical device products, 16 imported Class II medical device products, and 1 Hong Kong, Macao and Taiwan medical device product.

China is re-opening to the world after COVID isolation in 2023. As the only double-digit growth country in MedTech, 2nd largest market in the world, China market entry has its challenges to enter and sustain the growth. Leveraging our extensive experience, China Med Device provides regulatory, CRO and commercialization one-stop solutions for medical device, IVD, CDx and combination products in China. Connect with us by emailing  info@ChinaMedDevice.com to schedule an exploratory call and discover how our expertise can benefit your ventures in the thriving Chinese healthcare landscape.

Here is the complete list of imported products approved by China NMPA in October 2023.

Approved Class III Imported Products
Product NameRegistrant/Manufacturer
Cutting Base ColumnsInstitut Straumann AG
Artificial lensAlcon Laboratories, Incorporated
Radial Artery Access Distal Access CatheterMicro Therapeutics, Inc. DBA ev3 Neurovascular
Oil for assisted reproduction culturesFUJIFILM Irvine Scientific, Inc.
Carbon dioxide laser therapy machineAsclepion Laser Technologies GmbH
Ultrasonic suction equipmentIntegra LifeSciences (Ireland) Ltd
Single-use plasma surgical electrodesArthroCare Corporation
Continuous Blood Gas Monitoring ConnectorTerumo Cardiovascular Systems Corporation
Toric depth-of-focus extension IOLsJohnson & Johnson Surgical Vision, Inc.
Continuous Peripheral Ultrasound Guided Nerve Block KitB. Braun Melsungen AG
Intermaxillary fixation systemSynthes GmbH
X-ray computed tomography equipmentSiemens Healthcare GmbH
Peripheral Vascular Occlusion Balloon CatheterLeMaitre Vascular, Inc.
Blocking Balloon CatheterStryker Neurovascular
Absorbable Wound SutureCovidien llc
coronary balloon dilatation catheterGenoss Co., Ltd.
Abutments and accessoriesAPEIRON DENTAL S.r.l
Disposable Needle for Injection PenBecton Dickinson and Company
Disposable Membrane OxygenatorMedtronic, Inc.
Knee prosthesis components – femoral componentsZimmer Inc.
Tendon ligament fixation screwsConMed Corporation
rigid scleral contact lensValley Contax Inc.
Single-Use Extracorporeal Circulation Tap SensorTerumo Cardiovascular Systems Corporation
Hip prosthesis – double-action acetabular linerHowmedica Osteonics Corp.
Intestinal laminating stentsM.I.Tech Co., Ltd.
Disposable Blood Component SeparatorFresenius Kabi AG
Peripherally indented balloon dilatation catheterBard Peripheral Vascular, Inc.
Oil for assisted reproductionVitrolife Sweden AB
Approved Class II Imported Products
Single-use clamping deviceOlympus Media Systems, Inc.
Disposable Subcutaneous Tunneling ToolMedtronic Inc.
Magnetic field therapy equipmentBTL Industries Limited
cochlear implant sound processorCochlear Limited
Electric operating tableTRUMPF Medizin Systeme GmbH + Co. KG
Handles and accessories for surgical power systemsMedtronic Powered Surgical Solutions
Fully automated chemiluminescence immunoassay analyzerRoche Diagnostics GmbH
Non-absorbable surgical suturesAssut Europe S.p.A.
Dental implant drillsDENTIS.
Single-use sterile protective covermicrotek medical, inc.
Body Composition AnalyzerInBody Co., Ltd.
Dental implant drillsALTATEC GmbH
Non-absorbable suturesEthicon, LLC
nasopharyngeal airwayCovidien llc
Semiconductor laser therapyTheradome Inc.
Automatic Biochemistry AnalyzerRoche Diagnostics GmbH

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